510(k) · Cleared
ClearedLight Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millipore Corporation · OMG Antisera, Fluorescent, Human Metapneumovirus
Cleared on Mar 12, 2010 after an 88-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 12, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- OMG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Validated RT-PCR method followed by hi-directional sequencing for confirmation and… Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OMG devicesOMG Antisera, Fluorescent, Human Metapneumovirus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OMG
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OMG
53in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMG
No recall names OMG since 2007.
Adverse event reports per year · OMG
No MAUDE report names OMG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 3 | 53 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Light DiagnoSticS TM Human Metapneumovirus Direct Immuunoifluorescence Assay is intended for qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimen cell preparations from nasopharyngeal swab samples collected from patients with febrile respiratory illness. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Negative results do not preclude hMPV…
Read the full statement (104 words)
Light DiagnoSticS TM Human Metapneumovirus Direct Immuunoifluorescence Assay is intended for qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimen cell preparations from nasopharyngeal swab samples collected from patients with febrile respiratory illness. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other managenient decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by FDA cleared hMPV molecular assay.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093815: Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093815
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026